Optimal Timing of Routine Cervical Length Measurements During Anatomy Survey

NCT06822647 | Recruiting

• 1 other identifier: 16839
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine the optimal timing for measuring cervical length (CL) during fetal anatomy surveys in pregnant individuals. This study focuses on improving the accuracy of cervical length assessments, which are critical for identifying individuals at risk for preterm birth. The main questions it aims to answer are:

• Does measuring cervical length at the beginning of the anatomy survey result in a higher proportion of scans meeting the nine CLEAR (Cervical Length Education and Review) criteria compared to measuring at the end of the survey?
• Does the use of sepia-filtered ultrasound images improve the proportion of scans meeting the nine CLEAR criteria compared to conventional grayscale images? Researchers will compare two groups of participants randomized to have cervical length measured either at the beginning or at the end of the anatomy survey. Additionally, all participants will undergo cervical length measurements using both grayscale and sepia-filtered ultrasound imaging. Participants will:
• Receive a patient information sheet through MyChart explaining the study and standard cervical length screening during anatomy surveys.
• Provide verbal consent for a transvaginal ultrasound and study participation.
• Be randomized to have their cervical length measured at either the start or end of the fetal survey.
• Undergo cervical length measurement using both grayscale and sepia-filtered ultrasound imaging modalities.
• This study involves no additional risks beyond those of routine clinical care and aims to enhance clinical practice by identifying optimal methods for cervical length assessment during pregnancy.

Conditions

Cervical Insufficiency; Preterm Birth; Cervical Length Measurement

Outcome Measures

Primary Outcomes (1)

• Proportion of Cervical Length Measurements Meeting CLEAR Criteria at time of anatomy scan, between 18-24 weeks gestation, measured by transvaginal ultrasound

  The primary outcome is the proportion of transvaginal cervical length measurements that meet all nine CLEAR (Cervical Length Education and Review) criteria for accuracy. This will assess whether timing (beginning vs. end of anatomy survey) impacts measurement reliability.

  At the time of the fetal anatomy survey, specifically 18-24wks (one-time measurement per participant).

Secondary Outcomes (1)

• Proportion of Scans Meeting CLEAR Criteria Using Sepia-Filtered Imaging

  At the time of the fetal anatomy survey, specifically 18-24wks (one-time measurement per participant).

Other Outcomes (1)

• Interaction Between Timing and Imaging Modality on CLEAR Criteria Adherence

  At the time of the fetal anatomy survey, specifically 18-24wks (one-time measurement per participant).

Study Arms (2)

Beginning of Anatomy Survey

EXPERIMENTAL

Participants in this arm will undergo cervical length measurement via transvaginal ultrasound at the start of the fetal anatomy survey. This timing aims to evaluate whether early measurement improves adherence to the nine CLEAR criteria for accurate cervical length assessment. Measurements will also be conducted using grayscale and sepia-filtered ultrasound imaging.

Procedure: Cervical Length Measurement at the Beginning of the Anatomy Survey

End of Anatomy Survey

EXPERIMENTAL

Participants in this arm will undergo cervical length measurement via transvaginal ultrasound at the end of the fetal anatomy survey. This timing aims to evaluate whether late measurement improves adherence to the nine CLEAR criteria for accurate cervical length assessment. Measurements will also be conducted using grayscale and sepia-filtered ultrasound imaging.

Procedure: Cervical Length Measurement at the End of the Anatomy Survey

Interventions

Cervical Length Measurement at the Beginning of the Anatomy Survey PROCEDURE

This intervention involves performing a transvaginal ultrasound to measure cervical length at the beginning of the fetal anatomy survey. The procedure includes using both grayscale and sepia-filtered imaging to evaluate adherence to the nine CLEAR criteria for accurate cervical length assessment.

Beginning of Anatomy Survey

Cervical Length Measurement at the End of the Anatomy Survey PROCEDURE

This intervention involves performing a transvaginal ultrasound to measure cervical length at the end of the fetal anatomy survey. The procedure includes using both grayscale and sepia-filtered imaging to evaluate adherence to the nine CLEAR criteria for accurate cervical length assessment.

End of Anatomy Survey

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant individuals between 16 weeks and 23 weeks + 6 days of gestation.
• Presenting for a fetal anatomy survey at Henry Ford Health MFM ultrasound units.
• Consent to a transvaginal cervical length measurement as part of routine care.
• Agreement to participate in the study, including randomization for the timing of cervical length measurement.

You may not qualify if:

• History of preterm delivery.
• Diagnosis of cervical insufficiency.
• Declines or unable to consent to a transvaginal cervical length measurement.
• Patients receiving care at non-Henry Ford Health radiology clinics.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health New Center One

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Incompetence; Premature Birth

Condition Hierarchy (Ancestors)

Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Abortion, Habitual; Abortion, Spontaneous; Pregnancy Complications; Genital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Raminder Khangura, MD

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shelby A Masters, MD

CONTACT

313-671-5225; smaster1@hfhs.org

Raminder Khangura, MD

CONTACT

313-623-6412; rkhangu1@hfhs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No additional masking is used as this is an open-label study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomized to have cervical length measurements taken either at the beginning or the end of the anatomy survey.

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 12, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)